Kornimate/medical-research-clean huggingface dataset:
evaluation of didget tm world reports

Conditions: Diabetes

Summary: the purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both lay persons and healthcare professionals. with this data management system glucose results from the didget tm meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels.

diabetes data management programs upload glucose meter results to computers to provide information to lay persons and their health care professionals. with this data management system glucose results from the didget tm meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels. during the study subjects performed specific tasks, such as uploading meter results and displaying reports. the study evaluates the subjects' success in using the software program, the program's ease of use, clarity and usefulness of user instructions, and user satisfaction with the diabetes data management program.

Eligibility criteria:
inclusion criteria: * lay users must be: 1. be at least 18 years of age 2. have diabetes or be the parent or legal guardian of a child with diabetes 3. be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month 4. be able to speak, read, and understand english 5. have experience using a pc, navigating software programs, or browsing the internet * healthcare professionals must: 1. have experience using the internet 2. have experience using diabetes data management software in the medical office exclusion criteria: 1. person working for a competitive medical device company 2. person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.
video colposcopy in women with dysplasia

Conditions: Uterine Cervical Dysplasia

Summary: to assess the effect of live video-colposcopy on women´s anxiety.


Eligibility criteria:
inclusion criteria: * women referred for colposcopy due to cervical abnormalities * we included women if they attended colposcopy for the first time exclusion criteria: * pregnant women * presence of a language barrier * known anxiety disorder or depression * history of conization or other treatments * known oncological disorder * inadequate colposcopy

Keywords: live video-colposcopy cervical dysplasia anxiety randomized controlled trial colposcopy
a trial of ferumoxytol for the treatment of iron deficiency anemia in pediatric participants with chronic kidney disease

Conditions: Iron Deficiency Anemia

Summary: study evaluating the efficacy and safety of intravenous (iv) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (ckd).

study amag-fer-ckd-251 was a study evaluating the efficacy and safety of iv ferumoxytol in pediatric participants with dialysis-dependent ckd. study amag-fer-ckd-252 (nct01155388) was a study evaluating the efficacy and safety of iv ferumoxytol in pediatric participants with nondialysis-dependent ckd. due to significant challenges with enrollment for both studies, study amag-fer-ckd-252 was combined with study amag-fer-ckd-251 and enrollment continued under study amag-fer-ckd-251. the enrollment number (n=14) includes the number of participants for both amag-fer-ckd-251 and amag-fer-ckd-252 studies, combined. participants were enrolled by age cohorts in a stepwise manner following a safety review by the data safety monitoring board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest: randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years.

Eligibility criteria:
key inclusion criteria for the combined amag-fer-ckd-251 and amag-fer-cdk-252 studies include: 1. males or females 6 months to \<18 years of age 2. ckd non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to screening 3. had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dl) and b) with either transferrin saturation level ≤40% or ferritin level \<100 nanograms/milliliter (ng/ml) 4. female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to screening and agreed to remain on birth control until completion of participation in the study key exclusion criteria for the combined amag-fer-ckd-251 and amag-fer-cdk-252 studies include: 1. history of allergy to either oral or iv iron 2. hemoglobin level ≤7.0 g/dl 3. serum ferritin level \>600 ng/ml 4. female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test

Keywords: iron deficiency anemia feraheme ferumoxytol ckd pediatric dialysis-dependent nondialysis-dependent
a study of jr-141 in patients with mucopolysaccharidosis ii

Conditions: Mucopolysaccharidosis II

Summary: a phase ii/ iii multicenter, open-label, single-group, designed to evaluate the efficacy and safety of study drug for the treatment of the mps ii.


Eligibility criteria:
inclusion criteria: 1. capable of providing written consent by himself (not mandatory for those aged under 20 years at the time of informed consent process, or those who is impossible to obtain consent from the patient himself due to intellectual disabilities associated with mps ii.) 2. in the case of a patient who is under the age of 20 years or from whom it is not possible to obtain consent due to intellectual disabilities associated with mps ii, he may be included if written consent can be provided by legal representative (however, written consent should be obtained from the patient himself too, whenever possible) 3. males with confirmed diagnosis of mps ii, based on deficient activity of iduronate-2-sulfatase (ids) in leucocytes, plasma or fibroblasts and/or pathogenic mutations identified in the ids gene, etc. 4. naïve patients or patients who are receiving stable enzyme replacement therapy with elaprase for more than 8 weeks before the observational period starts. exclusion criteria: 1. previous engrafted hsct, excluding those who need enzyme replacement therapy even after hsct. 2. judged by the investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking position for lumbar puncture due to joint contracture or those who are likely experience difficulty breathing during the lumbar puncture process. 3. judged by the investigator or subinvestigator to be ineligible to participate in the study due to a history of serious drug allergy or sensitivity. 4. patients who have received other investigational product within 4 months before enrollment in the study. 5. otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study.
a study to determine the role of toll-like receptor-4 expression in patients with interstitial cystitis/bladder pain syndrome

Conditions: Cystitis, Interstitial; Painful Bladder Syndrome

Summary: this is a prospective pilot study, with a recruitment goal of 60 patients. patients who are female, above the age of 18, and with a diagnosis of ic/bps based on clinical criteria and o'leary sant icpi and icsi scores undergoing cystoscopy, hydrodistention and bladder biopsy will be included. the bladder biopsies will be evaluated for tlr4 expression, and sent for histological assessment of mast cell count. additionally, data will be collected at baseline, day of surgery, day 7, day 14 and day 28. data will include validated questionnaires, lower urinary tract symptoms, and recorded pain medication use.


Eligibility criteria:
inclusion criteria: 1. patients must be a candidate for cystoscopy, hydrodistention and bladder biopsy. 2. participant must have subjective complaints of 1. urinary urgency, relieved with voiding, or 2. urinary frequency; ≥ 8 voids per day, or 3. pelvic pain, pressure, or discomfort 2. gender of subjects: subjects in this study will be female. pregnant women and breastfeeding women will be excluded due to unknown risk of study medication on pregnancy and fetus or nursing infants. 3. age of subjects: age of subjects will range from 18 to 90 years. 4. racial and ethnic origin: there are no enrollment restrictions based upon race or ethnic origin. the racial and ethnic distribution of subjects is entirely based on the population of patients at the study site. 5. other inclusion criteria: 1. participant must give written informed consent to participate in the study 2. participant must be able to make decisions for herself 3. participant must not have had a uti within 7 days prior to start of the study 4. female participants who are with a positive pregnancy test exclusion criteria: to participate in the study subjects must not meet any of the following criteria: 1. participant is currently pregnant or breastfeeding 2. participant has a positive urinary pregnancy test at the time of screening 3. participant is currently or has been on antibiotic therapy with the last 7 days prior to the start of the study 4. participant is currently in another trial 5. participant has an active s3 nerve stimulator implanted or has ptns 6. participant has had intravesical botulinum toxin injection in 6 months prior to starting the study 7. participant has grade iii or iv pelvic organ prolapse 8. participant has history of bladder cancer 9. participant has a neurological disease including, but not limited to, multiple sclerosis, parkinson's disease, alzheimer's disease, spinal cord injury, brain injury, stroke or dementia 10. participant has urinary frequency of less than 8 times/day 11. participant has bladder or lower ureteral calculi 12. participant has active genital herpes 13. participant has urethral diverticulum 14. participant has chemical cystitis 15. participant has radiation or tuberculosis cystitis
bi 655066 (risankizumab) compared to placebo in japanese patients with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: this is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of bi 655066 (risankizumab).

participants were randomized to receive either placebo, risankizumab 75 mg, or risankizumab 150 mg in part a. all participants received 2 injections to maintain the blind: the placebo arm received 2 injections of placebo, the risankizumab 75 mg arm received one injection of risankizumab 75 mg and one injection of placebo, and the risankizumab 150 mg arm received 2 injections of risankizumab 75 mg. participants who received placebo in part a switched to risankizumab in part b; participants who received risankizumab (75 mg or 150 mg) in part a continued to receive the same treatment (risankizumab 75 mg or 150 mg) in part b.

Eligibility criteria:
inclusion criteria: * have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. duration of diagnosis may be reported by the patient. * have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both screening and baseline (randomisation): 1. have an involved body surface area (bsa) ≥10% and 2. have a psoriasis area and severity index (pasi) score ≥12 and 3. have a static physician global assessment (spga) score of ≥3. exclusion criteria: * patients with 1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular) 2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment * previous exposure to bi 655066

Keywords: bi 655066 abbv-066 risankizumab
a study to assess flx-787 in subjects with motor neuron disease experiencing muscle cramps.

Conditions: Motor Neuron Disease

Summary: the commend study will assess the safety and effectiveness of flx-787 in men and women with motor neuron disease \[including amyotrophic lateral sclerosis (als), primary lateral sclerosis (pls) or progressive muscular atrophy (pma)\] experiencing muscle cramps. participants will be asked to take two study products during the course of the study. one of these study products will be a placebo. approximately 120 participants in approximately 30 study centers across the united states are expected to take part. participants will be in the study for approximately 3 months and visit the study clinic 3 times.


Eligibility criteria:
inclusion criteria: * documented diagnosis of motor neuron disease (mnd) \[including amyotrophic lateral sclerosis (als), primary lateral sclerosis (pls) or progressive muscular atrophy (pma)\] * expected survival \> 6 months * weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes) exclusion criteria: * presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers * presence of laryngospasm or significant swallowing problems * presence of percutaneous endoscopic gastrostomy, esophagogastroduodenoscopy, or g-tube * unable or unwilling to discontinue medications for cramps and/or opiates * inability to tolerate a spicy sensation in the mouth or stomach * actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol * intention to change the current level of tobacco use or use of nicotine-containing products (i.e., new smokers or those actively trying to quit may not enrolled) * participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening

Keywords: motor neuron disease neurodegenerative diseases nervous system diseases neuromuscular diseases amyotrophic lateral sclerosis primary lateral sclerosis progressive muscular atrophy muscle cramps muscle cramping als mnd pma pls flx-787
an observational study to assess next generation emulsion preservative free eye drops (nge-ud) on dry eye symptoms and quality of life of adult participants with mild to moderate dry eye disease (ded)

Conditions: Dry Eye

Summary: dry eye disease (ded) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. this study will evaluate next generation emulsion preservative free eye drops (nge-ud) in adult participants with dry eye symptoms and who are high digital device users. nge-ud is an over-the-counter (otc) monograph drug indicated for the temporary relief of symptoms of eye dryness. participants will administer 1 drop of nge-ud on day 1 for the acute phase of the study, after day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through day 15. around 50 adult participants will be enrolled at one site in the united states. there is expected to be no additional burden for participants in this trial. study visits may be conducted on-site as per standard of care.


Eligibility criteria:
inclusion criteria: * during a routine visit, investigator will decide whether artificial tears are the appropriate treatment for potential participants with dry eyes and will then consider enrollment into this study. * participant with at least one sign of dry eye: * three consecutive tear break-up time (tbut) tests \<= 10 seconds in at least one eye at screening visit or; * grade 1 to 4 (modified national eye institute \[nei\] grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that is related to dry eye in at least 1 eye at both at screening visit. * use of digital devices of 8 hours or more per day. * adult participants who answer yes to the following questions: * do you use digital devices at least 8 hours per day? yes or no * are your eyes dry, irritated while using a digital screen like a computer or smartphone? yes or no exclusion criteria: * use of artificial tears in the last 24 hours. * current use of more than 4 drops of artificial tears per day in each eye. * use of dry eye treatment other than artificial tears. * are currently on ocular medications.

Keywords: dry eye next generation emulsion preservative free eye drops (nge-ud) agn-optiveplus
assessing short-term treatment satisfaction and quality of life in patients with hidradenitis suppurativa initiated on secukinumab.

Conditions: Hidradenitis Suppurativa

Summary: this study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (qol) in patients with hidradenitis suppurativa (hs) in real-world settings, especially in the gulf region.

this is a 24-week longitudinal single-arm prospective study based on data collected from emrs along with patient-reported outcomes questionnaires (tsqm and dlqi) to evaluate patient-reported satisfaction and early quality of life experiences among hs patients who are newly initiated on secukinumab. we will be using questionnaires at baseline and at week 24 to report on pre-defined outcomes in a representative hs population across the united arab emirates. the data will be collected using an electronic case report form (ecrf) from both data sources (electronic medical report and questionnaires).

Eligibility criteria:
inclusion criteria: * patient with a confirmed diagnosis of active moderate to severe hs (hurley score 2-3) * male or female adult patients ≥ 18 years of age at the time of data collection * patient newly initiated on secukinumab (first dose to coincide within 1 month of the signature of the informed consent) * patients with a diagnosis of hs who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion. * patients with a diagnosis of hs who have a history of previous treatment with adalimumab or any other anti-tnf agent as part of their routine clinical management or biologic naïve are eligible for inclusion. * agreed to sign an informed consent to be able to fill in the questionnaires. exclusion criteria: * patients not fulfilling any of the abovementioned inclusion criteria. * patient's refusal to be included in the study or refusal to sign the informed consent.
study of intravenous (iv) methylnaltrexone bromide (mntx) in the treatment of post-operative ileus (poi)

Conditions: Post-Operative Ileus (POI)

Summary: to evaluate the safety and efficacy of mntx in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the mntx regimen than the equivalent assessment using a placebo regimen.


Eligibility criteria:
inclusion criteria: * male and female participants at least 18 years of age. * all participants must meet american society of anesthesiologists (asa) physical status i, ii, or iii. * participants must sign an informed consent form (icf). * participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia. * females of childbearing potential must have a negative serum pregnancy test at the screening visit. * negative for history of chronic active hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection. exclusion criteria: * participants who received any investigational new drug in the 30 days prior to screening visit. * females who are pregnant or lactating.
care for late stage parkinsonism

Conditions: Parkinson's Disease; Late Stage Parkinson's Disease

Summary: the aim of this project is to evaluate the needs and provision of care for patients in the late stages of parkinsonism and their carers in several european countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. the investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six european countries. the systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. national and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. a systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage parkinsonism. the investigators will also evaluate potentially useful outcome measures for use in this patient group. in addition to charting the needs and current care provision for late stage parkinsonism in different european countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.


Eligibility criteria:
inclusion criteria: * hoehn and yahr stage (hy) iv or v in the "on"-state * disease duration of at least 7 years exclusion criteria: * symptomatic parkinsonism

Keywords: parkinson's disease, late stage
study of the incidence of surgical site infections developed by patients hospitalized in the wards of a large teaching hospital in rome, italy

Conditions: Surgical Site Infection

Summary: the surgical departments of the hospital were included in the study on a rotational basis over a period of 5 months. all patients undergoing surgery during this period were enrolled in the study. the data collection in each department lasted 6 months (8 in the case of the use of prostheses) of which: * 5 months of continuous survey of hospitalized patients * 30 days of post-operative surveillance for all operations, 90 days for operations involving the use of prosthetic material surveillance ends when a surgical site infection occurs, even if the event is prior to 30 or 90 days. for each surgery, information was recorded such as the type of surgery, duration, asa score, prophylaxis.


Eligibility criteria:
inclusion criteria: * patient undergoing surgery exclusion criteria: -